Analysis Confirms Combination Inhalers Don’t Increase Asthma-Related Death Risk

Analysis Confirms Combination Inhalers Don’t Increase Asthma-Related Death Risk

Four safety trials have concluded that popular combination inhalers — like Advair (fluticasone/salmeterol) and Symbicort (budesonide/formoterol) — are not associated with an increased risk of asthma-related hospitalizations or deaths, undermining previous findings. LABAs (long-acting beta agonists) such as salmeterol and formoterol, and combination products containing them, received a boxed warning in 2003 because findings at the time suggested that LABAs were associated with serious adverse outcomes, including asthma-related hospitalization, intubation and death.

In 2011, the FDA required the manufacturers of the combination inhalers to perform studies where they compared an inhaled glucocorticoid (corticosteroid) – such as fluticasone or budesonide – plus a LABA (combination therapy) with an inhaled glucocorticoid alone. The analysis included 36,010 patients who participated in the 4 trials. In each trial, patients were randomly assigned to receive a combination therapy (inhaled glucocorticoid plus a LABA) or an inhaled glucocorticoid alone.

The results, details of which were recently published in the New England Journal of Medicine, indicated that there is not a higher risk of severe asthma-related outcomes (endotracheal intubation or death) among patients who receive combination therapy than among those who receive an inhaled glucocorticoid alone.

In December 2017, the results prompted the FDA to remove the “black box” warning from combination products that warned of an increased risk of asthma-related deaths. However, medications that contain just a LABA retain a boxed warning of an increased risk of asthma-related death.


Alanna McCatty

Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.


Did you find this article helpful?


Latest News

News Scan: Breast Cancer, THC Overdose, Carpal Tunnel Syndrome, Junk Food

News Scan: Breast Cancer, THC Overdose, Carpal Tunnel Syndrome, Junk Food

Breast cancer tops the list this week with two research studies concluding worse news than expected. For those who continue to claim that no one overdoses on cannabis or THC, see the story below. Never underestimate how much people will underestimate the power of “herbs” to harm. Carpal tunnel brought…

News Scan: Warfarin, A-Fib, Lavender Oil and Dopamine Agonist Medicine

News Scan: Warfarin, A-Fib, Lavender Oil and Dopamine Agonist Medicine

Every so often a lay person like me slaps her forehead and says out loud, “what took so long?” A veggie works better than a medicine, why not use the veggie? Talking to patients in their home leads to better understanding by the patients? Of course. And less intuitive but…